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Dolce and Gabbana Everlast Foundation SPF 20 07N Light OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL Emulsion — NDC 84003-0007-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dolce and Gabbana Everlast Foundation SPF 20 07N Light OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL Emulsion — NDC 84003-007-01 (Billing 84003-0007-01)

by Dolce & Gabbana Beauty S.R.L · 1 BOTTLE, PUMP in 1 CARTON / 27 mL in 1 BOTTLE, PUMP

This is a package of Dolce and Gabbana Everlast Foundation SPF 20 07N Light OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL Emulsion from Dolce & Gabbana Beauty S.R.L, marketed since May 2024 and currently FDA-listed.

NDC 84003-0007-01
🏷️ FDA NDC (as labeled) 84003-007-01 billing pads the product segment with a zero
This package
Contains27 mL in 1 bottle, pump Pack sizes2 compare ↓
Product page 84003-0007-00 Also comes in: 27 mL 84003-007-00
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 84003-007-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84003 labeler · 007 product · 01 package
Package marketed since
May 1, 2024
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2026
Barcode (UPC)
8054754401882, 8054754402285
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84003-007-01
Product NDC 84003-007
11-digit billing NDC 84003000701
UNII 4X49Y0596W, 5A68WGF6WM, 15FIX9V2JP, SOI2LOH54Z
UPC 8054754401882, 8054754402285
Application # M020
SPL Set ID d4c76bc5-205b-45fd-8a02-4f4b17458503
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-01
Route TOPICAL
Dosage form EMULSION
Substance OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 84003-007-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 84003-0007-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

This is a topical foundation emulsion marketed as an over-the-counter sunscreen product under FDA's OTC monograph rules. It contains four active sunscreen ingredients: octisalate and octocrylene, which function as ultraviolet (UV) light absorbers; and titanium dioxide and zinc oxide, which function as UV reflectants. Together, these ingredients are typically used to help protect skin from sun exposure by filtering and blocking UV rays. The product is formulated as a liquid foundation with color pigmentation intended for facial application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 27 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84003-0007-00 84003-007-00 Main listing 1 BOTTLE, PUMP in 1 CARTON / 27 mL in 1 BOTTLE, PUMP 2024-05-01 — Active
84003-0007-01 You're viewing this 1 BOTTLE, PUMP in 1 CARTON / 27 mL in 1 BOTTLE, PUMP Sample 2024-05-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, pump in 1 carton / 27 ml in 1 bottle, pump.
What NDC number is used to bill for this package of Dolce and Gabbana Everlast Foundation SPF 20 07N Light OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL Emulsion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dolce and Gabbana Everlast Foundation SPF 20 05N Light 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0005-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 07N Light 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mLthis 84003-0007-01 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 20C Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0020-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 23W Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0023-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0028-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 37W Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0037-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 40C Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0040-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 06W Light 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0006-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 15N Light Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0015-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 16N Light Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0016-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0032-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 33N Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0033-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 36N Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0036-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 38C Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0038-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 02C Light 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0002-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 13C Light Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0013-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 01N Light 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0001-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 08W Light 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0008-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 12N Light Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0012-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 19W Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0019-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0026-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0031-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 10N Light Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0010-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 18N Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0018-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 22N Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0022-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 24N Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0024-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0030-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 35W Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0035-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 39N Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0039-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 11W Light Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0011-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 14W Light Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0014-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 17W Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0017-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 21W Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0021-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 34W Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0034-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 04C Light 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0004-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0025-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0029-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 03W Light 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0003-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 09C Light Medium 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0009-00 Dolce 1 bottle — — FDA listed —
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium Deep 35 mg/mL; 50 mg/mL; 5 mg/mL; 18.8 mg/mL 84003-0027-00 Dolce 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII SDS87L369F
    A natural oil extracted from avocado fruit. It's used as an emollient and skin-conditioning agent in topical formulations to help soften and smooth the product's texture.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII DAC8GQQ57F
    A silicone-based compound derived from coconut oil that acts as an emulsifier and skin conditioning agent. It helps distribute oils and water evenly in topical formulations and improves how the product spreads on the skin.
  • UNII Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII S73ZQI0GXM
    Methyl trimethicone is a silicone-based lubricant and glidant used in tablets and capsules. It reduces friction between particles and equipment during manufacturing, helping the medicine flow smoothly and compress evenly.
  • UNII 75UY509K9B
    A fruit extract from the prickly pear cactus plant, used as a natural colorant and thickener in medicines. It adds color, texture, and plant-based ingredient appeal to formulations.
  • UNII 965K72OQXO
    A silicone-based ingredient made from polymers that are chemically linked together. It works as an emulsifier and texture modifier to help blend oil and water components and create a smooth, stable consistency in cosmetic or topical formulations.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 59Z907ZB69
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles, helping powders and tablets flow smoothly during manufacturing and use.
  • UNII RS999V57DU
    Pomegranate fruit rind is a natural plant extract used as a coloring agent and flavoring ingredient in medicines. It may provide a reddish tint and fruity taste to tablets, capsules, or liquids.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 8W46YN971G
    Sodium dehydroacetate is a salt derived from dehydroacetic acid, a compound used as a preservative. It helps prevent mold, bacteria, and yeast growth in medicines, extending shelf life and maintaining product safety.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

22 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesWATER/EAU (AQUA), DIMETHICONE, CAPRYLYL METHICONE, TRIMETHYLSILOXYSILICATE, METHYL TRIMETHICONE, POLYMETHYLSILSESQUIOXANE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, BUTYLENE GLYCOL, PEG-10 DIMETHICONE, PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, POLYIMIDE-1, CETEARYL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, POLYPHENYLSILSESQUIOXANE, PHENOXYETHANOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, SODIUM CHLORIDE, POTASSIUM SORBATE, SODIUM DEHYDROACETATE, ALUMINA, TRIETHOXYCAPRYLYLSILANE, C20-24 OLEFIN, SILICA, TOCOPHERYL ACETATE, PERSEA GRATISSIMA (AVOCADO) FRUIT EXTRACT, PUNICA GRANATUM PERICARP EXTRACT, LAURYL DIMETHICONE, OPUNTIA TUNA FRUIT EXTRACT, TOCOPHEROL; +/- MAY CONTAIN: TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499)

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDolce & Gabbana Beauty S.R.L
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84003
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio59 products on file

More NDCs from Dolce & Gabbana Beauty S.R.L labeler code 84003

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

Uses Helps prevent sunburn If uses directed with others sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 93 words ▾

Directions Apply generously 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.-2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: ask a doctor SHAKE WELL BEFORE USE

⚠️ Warnings 54 words ▾

Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 14 words ▾

Active ingredients Octisalate 3.5% Octocrylene 5% Titanium dioxide 0.5% Zinc Oxide 1.88% Purpose Sunscreen

🧪 Inactive Ingredients 83 words ▾

Inactive ingredients WATER/EAU (AQUA), DIMETHICONE, CAPRYLYL METHICONE, TRIMETHYLSILOXYSILICATE, METHYL TRIMETHICONE, POLYMETHYLSILSESQUIOXANE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, BUTYLENE GLYCOL, PEG-10 DIMETHICONE, PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, POLYIMIDE-1, CETEARYL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, POLYPHENYLSILSESQUIOXANE, PHENOXYETHANOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, SODIUM CHLORIDE, POTASSIUM SORBATE, SODIUM DEHYDROACETATE, ALUMINA, TRIETHOXYCAPRYLYLSILANE, C20-24 OLEFIN, SILICA, TOCOPHERYL ACETATE, PERSEA GRATISSIMA (AVOCADO) FRUIT EXTRACT, PUNICA GRANATUM PERICARP EXTRACT, LAURYL DIMETHICONE, OPUNTIA TUNA FRUIT EXTRACT, TOCOPHEROL; +/- MAY CONTAIN: TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499)

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin.

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 6 words ▾

Package Labeling: Label07

Package Labeling:Tester Tester07

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Dolce & Gabbana Beauty S.R.L. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (84003-0007-00). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Dolce & Gabbana Beauty S.R.L is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 84003-0006-00 · Dolce 84003-0008-00 · Dolce →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.